The following data is part of a premarket notification filed by Illuminoss Medical, Inc. with the FDA for Illuminoss Photodynamic Bone Stabilization System.
| Device ID | K183145 |
| 510k Number | K183145 |
| Device Name: | IlluminOss Photodynamic Bone Stabilization System |
| Classification | Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated |
| Applicant | IlluminOss Medical, Inc. 993 Waterman Avenue East Providence, RI 02914 |
| Contact | Robert Rabiner |
| Correspondent | Hollace Rhodes Musculoskeltal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | QAD |
| CFR Regulation Number | 888.3023 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2018-12-13 |
| Summary: | summary |